ArticleTrials2016
Stopping guidelines for an effectiveness trial: what should the protocol specify?
Article in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Evaluation of 'implications for research' statements in systematic reviews of interventions in advanced cancer patients - a meta-research study.BMC medical research methodology · 2023Pooled it
- A systematic review of randomised controlled trials with adaptive and traditional group sequential designs - applications in cardiovascular clinical trials.BMC medical research methodology · 2023Pooled it
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- Randomized, Multicenter Trial of ARTSS-2 (Argatroban With Recombinant Tissue Plasminogen Activator for Acute Stroke).Stroke · 2017Trial
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- The Requirements of Managing Phase I Clinical Trials Risks: The British and Italian Case Studies.Epidemiologia (Basel, Switzerland) · 2024Article
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- Does prefusion F protein-based respiratory syncytial virus immunization in pregnancy safely promote transplacental transfer of neutralizing antibodies?Journal of perinatology : official journal of the California Perinatal Association · 2024Article
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- Factors influencing the statistical planning, design, conduct, analysis and reporting of trials in health care: A systematic review.Contemporary clinical trials communications · 2022Review
- Effect of standardized vs. local preoperative enteral feeding practice on the incidence of NEC in infants with duct dependent lesions: Protocol for a randomized control trial.Frontiers in cardiovascular medicine · 2022Article
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- Statistical fundamentals on cancer research for clinicians: Working with your statisticians.Clinical and translational radiation oncology · 2021Review
- Using a Mobile Health Intervention (DOT Selfie) With Transfer of Social Bundle Incentives to Increase Treatment Adherence in Tuberculosis Patients in Uganda: Protocol for a Randomized Controlled Trial.JMIR research protocols · 2021Article
- Practical risk management in early phase clinical trials.European journal of clinical pharmacology · 2019Article
- Not all that glitters is gold: A guide to critical appraisal of animal drug trials in epilepsy.Epilepsia open · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundDespite long-standing problems in decisions to stop clinical trials, stopping guidelines are often vague or unspecified in the trial protocol. Clear, well-conceived guidelines are especially important to assist the data monitoring committees for effectiveness trials. MAIN TEXT: To specify better stopping guidelines in the protocol for such trials, the clinical investigators and trial statistician should carefully consider the following kinds of questions: 1. How should the relative importance of the treatment benefits and hazards be assessed? 2. For decisions to stop a trial for benefit: (a) What would be the minimum clinically important difference for the study population? (b) How should the probability that the benefit exceeds that difference be assessed? (c) When should the interim analyses include data from other trials? (d) Would the evidence meet state-of-the-art standards for treatment recommendations and practice guidelines? 3. Should less evidence be required to stop the trial for harm than for benefit? 4. When should conventional stopping guidelines for futility be used for comparative effectiveness trials?
conclusionBoth clinical and statistical expertise are required to address such challenging questions for effectiveness trials. Their joint consideration by clinical investigators and statisticians is needed to define better stopping guidelines before starting the trial.
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